Increasing diversity in clinical trial enrollment may impact who receives early application of recently approved innovations, based on findings from a study conducted on behalf of the Heart Failure Collaboratory and being presented at ACC.24 in Atlanta, GA. The findings, which were also published in JACC: Heart Failure, underscore the need for "practical strategies to improve inclusion by selecting trial sites in U.S. regions where diverse populations reside," according to Philip B. Adamson, MD, MSc, FACC, and colleagues.

The study compared demographics of more than 2 million Medicare patients hospitalized for heart failure (HF) with roughly 11,000 Medicare beneficiaries who were the first to receive an implantable pulmonary artery pressure sensor (PAS). Researchers also compared characteristics of the 550 participants in the CHAMPION trial with both groups.

Among the broader Medicare population, 80.9% were White, 51.5% were women, 13.3% were African American, 1.9% were Hispanic and 1.3% were Asian. In the PAS group, 82% of patients were White, 13% were African, 1% were Hispanic and Asian, respectively, and 29% were female. Among those enrolled in the CHAMPION trial, 24% were African American, 2% were Hispanic, 1% were Asian and 27% were women.

In other findings, researchers found the majority of patients in both the broader Medicare group and the PAS groups were over 65 years old. Those patients in the broader Medicare group under the age of 65 years were more likely to be African American (33%) and male (58%), while those over the age of 65 were more likely to be White (84%) and women (53%).

When comparing demographic data with the CHAMPION trial, researchers noted that patients enrolled in the trial and those who were the first to receive a PAS were similar. In both cases, African American, Hispanic and Asian patients were "adequately represented," they said, while women who account for roughly half of all HF hospitalizations were underrepresented.

"Characteristics of patients enrolled in clinical trials must match those with the disease process studied to adequately assess benefit or adverse effects," researchers said. "The results of this study present the possibility that trial demographics may also have implications for which patients receive a newly approved intervention, potentially identifying another factor contributing to ongoing health inequities."

A separate state-of-the-art review article from the Heart Failure Collaboratory, also being presented at ACC.24 and published in JACC: Heart Failure, addresses the urgent need to recruit and train new members of data monitoring committees (DMCs) – an important component of many randomized clinical trials. The article provides an overview of a DMC training workshop developed by the Collaboratory that aims to provide a standardized approach to data reporting, DMC conduct, and new member training that can be used as a model to train the next generation of DMS members.

"We declare a 'Call to Action,'" the authors write. "As a community committed to improving the outcomes of patients through therapeutic development … we must commit to enhancing the ecosystem by implementing procedures that will enhance the quality and excellence of clinical trials, including by improving the training of DMC members and others involved in providing leadership, and with attention to ensuring relevant diversity of members."

The Heart Failure Collaboratory is a multidisciplinary public-private consortium of academics, trialists, patients, industry representatives and government agencies that is working improve the efficiency, quality and effectiveness of clinical trials.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ACC24, ACC Annual Scientific Session, Heart Failure